Key result
The Sinovac EV71 vaccine achieved a 95.5% seroconversion rate in children aged 36-71 months, superior to the control EV71 vaccine (86.0%) and non-inferior to younger children (98.5%).
Why the study?
The Sinovac EV71 vaccine has demonstrated safety, immunogenicity, and efficacy in children aged 6-35 months, but further exploration was needed for its application in older children.
Does the Sinovac EV71 vaccine provide non-inferior immunogenicity and similar safety in children aged 36-71 months compared to a control EV71 vaccine or younger children?
RCT (n=900)
Double-blind
randomized
No
Does the Sinovac EV71 vaccine provide non-inferior immunogenicity and similar safety in children aged 36-71 months compared to a control EV71 vaccine or younger children?
Absolute Event Rate: 95.5% vs 86%
The Sinovac EV71 vaccine demonstrates good safety and immunogenicity in children aged 36-71 months, supporting its use in this older age group.
Supports Sinovac EV71 vaccination in 36-71-month-olds; extends RCT immunogenicity data to older preschoolers.
BACKGROUND: The Sinovac enterovirus 71 (EV71) vaccine has been given to children aged 6-35 months with good safety, immunogenicity, and efficacy. Further exploration is needed for the application of Sinovac EV71 vaccine in older children. METHODS: A phase III, double-blind, single-center, randomized, controlled, non-inferiority, and bridging-designed trial enrolled 300 participants aged 6-35 months and 600 participants aged 36-71 months. Non-inferiority and superiority analyses were made to determine the immunogenicity of Sinovac EV71 vaccine in older children (Older-S group), comparing with that of control EV71 vaccine in the same age group (Older-C group), or comparing with that of Sinovac EV71 vaccine in younger children (Younger-S group). RESULTS: The seroconversion rate of anti-EV71 in Older-S group (95.5%) was superior to that of Older-C group (86.0%), and non-inferior to that of Younger-S group (98.5%). For baseline seronegative participants, the geometric mean titer of Older-S group (370.0) was non-inferior to that of Older-C group (296.2) and superior to that of Younger-S group (176.5). Incidence of adverse reactions in Older-S group (47.0%) was similar to that of Older-C group (44.8%), or Younger-S group (49.8%). CONCLUSIONS: This study showed good safety and immunogenicity of Sinovac EV71 vaccine in children aged 36-71 months. CLINICAL TRIALS REGISTRATION: NCT03909074. URL: https://clinicaltrials.gov/ct2/show/NCT03909074?term=NCT03909074&draw=2&rank=1.
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Zhang et al. (2020) conducted an RCT in Enterovirus 71 (n=900). Sinovac EV71 vaccine vs. Control EV71 vaccine or Sinovac EV71 vaccine in younger children was evaluated on Seroconversion rate of anti-EV71. The Sinovac EV71 vaccine achieved a 95.5% seroconversion rate in children aged 36-71 months, superior to the control EV71 vaccine (86.0%) and non-inferior to younger children (98.5%).
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